Healthcare Industry News:  Age-related Macular Degeneration 

Devices Ophthalmology FDA

 News Release - November 3, 2006

Heidelberg Engineering Receives FDA Clearance for World's First Spectral Domain OCT and Laser Angiography Instrument

Spectralis(TM) HRA+OCT reveals previously undetected retinal structures

VISTA, Calif. & HEIDELBERG, Germany--(HSMN NewsFeed)--Heidelberg Engineering GmbH, the leading developer of laser diagnostics for ophthalmic applications, announced today the United States Food and Drug Administration (FDA) has granted clearance for the Spectralis(TM) HRA+OCT, the world's first commercial spectral domain optical coherence tomograph (OCT) combined with laser angiography.

This ground breaking development provides clinicians with never before seen details of the structure of the retina. This new product detects previously unrecognized structures, combining high resolution cross-sectional images of the retina with any of four imaging modalities: autofluorescence, infrared, fluorescein angiography, or ICG angiography. The new device scans the retina 100 times faster than older existing technology known as time domain OCT. Spectralis(TM) HRA+OCT is a spectral domain system, sometimes called fourier domain, which scans the retina at 40,000 scans per second, creating highly detailed images of the structure of the retina.

Because the OCT and HRA images are captured simultaneously, the clinician can be assured of the exact location of the area of interest and can correlate the outer visible retina structure with the internal structure.

"This new technology represents a dramatic leap in our ability to image complex macular disease," said Scott Cousins, MD, director, Duke Center for Macular Diseases, at Duke University. "The combination of these two cutting edge technologies will amplify our understanding of retinal structure and provide us with new insights into the biological processes of the retina."

The new product is built on the company's successful Heidelberg Retina Angiograph (HRA) platform, the first commercial angiography system to use lasers in combination with marker dyes such as sodium fluorescein and indocyanine green (ICG). Using the HRA instead of white light photography has allowed clinicians to capture detailed images of the blood vessel structure within the retina, a key diagnostic indicator for such common eye disease as Age-related Macular Degeneration and diabetic maculopathy. Another advantage of using lasers is the fast frame rate which enables movies of the blood flow, adding a new diagnostic dimension over traditional photography.

Of recent interest is the HRA's capability to cause certain retinal components to fluoresce in a process known as autofluorescence. Geographic atrophy of Age-related Macular Degeneration is being followed using autofluorescence as a potential early indicator of disease progression in the recently announced AREDS 2 clinical trial.

The new product will be presented at the upcoming American Academy of Ophthalmology meeting in November. The company expects to begin shipping the product in mid-2007.

About Heidelberg Engineering, Inc.

Headquartered in Heidelberg, Germany, this privately-held company is the leader in light-based diagnostics for ophthalmic applications and has the world's largest installed base of laser imaging equipment. The company designs, manufactures and markets a variety of diagnostic instruments for application in retina, glaucoma and cornea diseases. U.S. corporate offices are located in Vista, California.

Source: Heidelberg Engineering

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